Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants
Recruiting
Observational Study
Very Preterm Infants (<32 Weeks of Gestation)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 0 Days – 14 Days
- Sex
- Any
- Study type
- Observational
- Participants needed
- 20 (estimated)
- Sponsor
- Instituto de Investigacion Sanitaria La Fe · Other
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About This Trial
The AdVEMPrem study is exploring whether tiny particles called extracellular vesicles (EVs), which are naturally found in human milk, can help protect very premature babies from serious gut problems such as necrotizing enterocolitis (NEC). NEC is a dangerous condition that affects the intestines of preterm infants and can lead to long-term health issues.
Human milk is the best nutrition for babie…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Preterm infants born at \<32 weeks gestational age
* Age between 0 and 14 days of life at enrollment
* At risk of developing necrotizing enterocolitis (NEC)
* Written informed consent obtained from parent(s) or legal guardian(s)
Exclusion Criteria:
* Major congenital anomali…
Contacts